BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    560BC BIO CONSOLE

    MDR report key: 19546788 · Received June 17, 2024

    Report

    Report Number
    2184009-2024-00368
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 17, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWA
    PMA / PMN Number
    K080824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE REPORTED BATTERY FAILURE ALARM WAS VERIFIED DURING SERVICE. THE SERVICE TECHNICIAN'S INITIAL INSPECTION REVEALED THAT THE BATTERIES WERE EXPIRED BY FOUR YEARS. THE ISSUE WAS RESOLVED BY REPLACING THE BATTERIES. FURTHER TESTING REVEALED THAT THE POWER SUPPLY HAD FAILED. THE ISSUE WAS RESOLVED BY REPLACING THE POWER SUPPLY. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. NOTE: THE INSTRUMENT WAS SERVICED IN THE FACILITY BY A FIELD SERVICE TECHNICIAN. THE INSTRUMENT DID NOT RETURN TO A MEDTRONIC FACILITY FOR ANALYSIS/SERVICE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, THE CUSTOMER REPORTED A BATTERY FAILURE ALARM. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BATTERIES WERE INSTALLED IN 2016 AND THE LAST PREVENTATIVE MAINTENANCE SERVICE PE RFORMED ON THIS INSTRUMENT WAS IN 2018. THE CUSTOMER HAS NOT REQUESTED SERVICE FOR THIS INSTRUMENT SINCE 2018. THE LOT NUMBERS FOR THE BATTERIES THAT WERE REMOVED FROM THE INSTRUMENT ARE; 110 1715 AND 105 1715.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262956 560BC BIO CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA PERFUSION SYSTEMS 560BC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown